Check-Cap Redefining Colorectal Cancer Screening - CORPORATE PRESENTATION
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Check-Cap Redefining Colorectal Cancer Screening C O R P O R A TE P R E S E N TA TI ON July 2021 check-cap.com NASDAQ : CHEK
Safe Harbor Statement Forward-Looking Statements This presentation contains forward-looking statements about our expectations, beliefs or intentions regarding, among other things, our ongoing and planned product development and clinical trials; the timing of, and our ability to make, regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential number of patients who could utilize our product candidates; potential market size; our intellectual property position; the degree of clinical utility of our products, particularly in specific patient populations; our ability to develop commercial functions; expectations regarding product launch and revenue; our results of operations, cash needs; our financial condition, liquidity, prospects, growth and strategies; the industry in which we operate; and the trends that may affect the industry or us. In addition, from time to time, we or our representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, this presentation, various filings made by us with the Securities and Exchange Commission (“SEC”), press releases or oral statements made by or with the approval of one of our authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the factors summarized below. These factors include, but are not limited to, the following: our history of losses and our ability to continue as a going concern; our needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our clinical trials and other product development efforts; our reliance on one product or product line; the clinical development, commercialization and market acceptance of C-scan; our ability to receive de novo classification and other regulatory approvals for C-Scan; our ability to successfully complete clinical trials; our reliance on single-source suppliers; our reliance on third parties such as for purposes of our clinical trials and clinical development and the manufacturing, marketing and distribution of C-Scan; our ability to establish and maintain strategic partnerships and other corporate collaborations; our ability to achieve reimbursement and coverage from government and private third-party payors; the implementation of our business model and strategic plans for our business; the scope of protection we are able to establish and maintain for intellectual property rights covering C-Scan and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting Check-Cap is contained under the heading "Risk Factors" included in Check-Cap’s most recent Annual Report on Form 20-F for the fiscal year ended December 31, 2020, filed with the SEC on March 18, 2021, and in other filings that Check-Cap has made and may make with the SEC in the future. These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. Given these uncertainties, you should not rely upon forward-looking statements as predictions of future events. All forward-looking statements attributable to us or persons acting on our behalf included in, but not limited to, this presentation speak only as of the date hereof and are expressly qualified in their entirety by the foregoing. We undertake no obligations to update or revise forward-looking statements to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events. In evaluating forward-looking statements, you should consider these risks and uncertainties. This presentation shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction. The presentation contains information about an investigation-stage medical device product under development, which has not yet been approved by the United States Food and Drug Administration (“FDA”) for commercial distribution in the United States. All representations in this presentation are based upon investigations in certain clinical and other research, but which accordingly should not be construed as general claims for the safety or efficacy of the products when used by patients. 2
The Check-Cap Mission:
Enable Colorectal Cancer Prevention
through Precancerous Polyp Detection
3
Check-Cap at a Glance
• Prep-free capsule-based screening option for the health-conscious
population and those who cannot tolerate / avoid other screening procedures
• Target to improve global screening adherence and enable early intervention
and cancer prevention through detection of polyps before they may turn into
cancer
• Designed to address unmet need in a multibillion-dollar market
• CE Mark granted; Approved for sale in Israel
• Positive clinical data from U.S. pilot study and post-CE approval study
• IDE approval for pivotal study initiation and FDA Breakthrough Device
Designation
• Building out global supply chain
• Strong IP profile 4 4
Why Wait for Cancer?
Up to 90% 38.1%
of colorectal cancers can be
prevented by removing polyps1
Potential Polyp Progression
~ 1.5% present over 10-15 years
cancerous polyps4,5 (increasing malignancy rate (%)3)
6.1%
0% 0.9%
Average risk ~ 75% ~ 25%
population present present
(ages 50-75) no polyps5 polyps5
CRC: Third Most Diagnosed, Yet Least Prevented Cancer
Worldwide estimated number
Annual CRC Incidence (Worldwide) Economic Burden
of new cases in millions, 20201
2.3M 2.2M 1.9M 935,173 ~ $99B
1.9M* New cases1 Deaths1 Worldwide5
1.4M
1.1M
Estimated Annual CRC Incidence (U.S.) Economic Burden
150K 53,000 ~ $16B
New cases3 Deaths3 U.S alone (2018)4
Breast Lung Colorectal Prostate Stomach
* 60% increase expected by 20302
Source:
1. World Health Organization GLOBOCAN database. Accessed in May 2021
2. Arnold M, et al. Gut 2017;66:683–691.
3. American Society of Cancer. Cancer Facts and Figures 2021
4. National Cancer Institute. Cancer Trends Progress Report. Accessed in January 2020
5. Cancer Has Greater Economic Impact Than All Other Diseases. Zosia Chustecka. Medscape. August 2010
6
Current Screening Landscape - Unmet Need
~1 in 3 Germany2,*
people are not getting screened as recommended in the US1,* > 63%
China3,*
Ages ≥50 ~38% High
Fecal Immunochemical Test (FIT) Colonoscopy Not Screened Screened
or Fecal Occult Blood Test (FOBT)
BARRIERS TO COMPLIANCE
Main Modality BARRIERS TO COMPLIANCE
Colonoscopy - designed to detect polyps Laxative bowel preparation, Invasiveness, Sedation
FIT or FOBT - designed to detect cancer Stool Handling
Source:
1. Relates to ages 50 years and older, as of 2015. For colonoscopy, this includes adults that had a colonoscopy in the past 10 years or sigmoidoscopy in the past 5 years. For FIT this includes adults that had FIT or FOBT in the past year.
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf
2. For FIT this relates to 50-54 years old testing for fecal blood in 2014. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5341111/ , http://www.cancer-days.eu/res/file/presentations/2017/04-state-of-the-art-04b-seufferlein.pdf
3. Schreuders EH, Ruco A, Rabeneck L, et al. Colorectal cancer screening: a global overview of existing programmes. Gut 2015;64:1637-1649.
*Note that numbers are estimations 7
Multi-Billion Dollar Market Opportunity
UNITED STATES EUROPE CHINA
115M 283M 539M
Potential
Population
For Screening*
~$12B ~$28B ~$54B
Market
Opportunity**
Revised ACS guidelines recommending average risk population to begin screening at age of 45
Source:
*Population age groups 45-74. United Nations DESA/ Population Division – World Population Prospects 2019 (U.S, China and Europe). https://population.un.org/wpp/Download/Standard/Population/
**For average risk patients, aged 45-74, screened once every 10 years according to ACS’ guidelines, at average estimated C-Scan test cost of $1K. 8
Our Solution: Prep-Free Polyp Detection First and only patient-friendly preparation- free test to detect precancerous polyps and enable early intervention and cancer prevention Potential to help millions of busy, active people stay healthy through preventive screening with less life disruption Potential to motivate the younger, health-conscious patient population with increasingly higher CRC risk, to undergo screening earlier C-Scan® is not available for sale or clinical use in the U.S. 9
Capsule Based C-Scan® system
C-Scan® View
• Cloud based analysis suite
C-Scan® Cap
• Maps of colon’s inner surface
• Natural passage
• Ultra-low dose X-ray
scanning technology
C-Scan® Track
• Autonomous control
positioning and recording
C-Scan® is not available for sale or clinical use in the U.S. 10Polyp Presence Confirmed by Colonoscopy
C-Scan polyp presence detection analysis tools Colonoscopy Polyp size
findings + images measured by
Slice profiles Height map of colon inner surface 3D map of colon inner surface colonoscopy
5-10mm
Sessile polyps
10-20 mm
Single polyp
20 mm
Single sessile polyp 11C-Scan: A Prep-Free Patient-Friendly Test
1 2 3
At the Clinic Normal Daily Routine Physician Analysis
• Capsule ingestion • No special diet • Clinical data downloaded from Track to
C-Scan® View cloud
• C-Scan® Track attached to • Contrast agent + fiber
patient’s back with each meal • Pre - Analysis and bookmarking
of findings by Check-Cap’s expert
• Test takes 2-3 days
technician
• Patient is notified once capsule
• Cloud based Physician Suite –
is excreted naturally
review of bookmarks, analysis and
report (~30 min)
12C-Scan® Advantages
Patient
• Opportunity for preventive screening
• Patient-friendly test
• NO bowel preparation
• NO sedation, significant pain or discomfort
• NO significant interruption of daily routine
Physician
Physician Patient
• Potential for improved adherence to ACS screening
guidelines - alternative for patients refusing or unable to
undergo colonoscopy
• Potential for increased screening volumes
• Cloud-based analysis tool
• NO operating room required to perform the screening
Payer
Payer • Potential for reduced CRC incidence and mortality, by
enabling early intervention and cancer prevention, and
reduced overall cost associated with CRC treatment 13Clinical Evidence of C-Scan ® Performance
Post CE approval study* results1 for precancerous polyp detection
C-Scan Sensitivity FIT Sensitivity FIT Detection Rate
100% 76%
76% Sensitivity**
66%
29% 25%
23%
All patients* Polyps ≥10mm Polyps ≥40mm
82%
(≥30mm Polyps – 38.1% malignancy rate2)
Specificity
*90 patients evaluated of 142 enrolled, evaluation was obtained implementing a gender-based motility analysis. Results of both C-Scan and FIT were compared to colonoscopy.
** For polyps ≥10 mm
Source:
1. http://ir.check-cap.com/2019-07-09-Check-Cap-Announces-Positive-Final-Results-from-Its-Post-CE-Approval-Study-of-the-C-Scan-R-System
2. Pickhardt at al. Clin. Gastro. And Hep. 2010; 8:610 14U.S. Pilot Study Demonstrating Safety and Patient Satisfaction
28 evaluable study subjects (out of 40 who completed the study) in two sites,
NYU Grossman School of Medicine and Mayo Clinic, Rochester1
Primary endpoint achieved; no device or test related serious adverse events
(SAEs) were reported
All patients who underwent the study complied with the procedure and
completed a questionnaire after the test, reporting higher satisfaction
with C-Scan compared to colonoscopy
Agreement between C-Scan and colonoscopy in detection of polyps for
evaluable patients was consistent with data from the post-CE approval study2,3
Source:
1. Prepless Colon Capsule Technology: New Research Examines This Less Invasive Approach to Colorectal Cancer Screening. Mayo Clinic Digestive Diseases Update. Gastroenterology and Hepatology. Vol 8, No.1, 2020.
2. http://ir.check-cap.com/2019-07-09-Check-Cap-Announces-Positive-Final-Results-from-Its-Post-CE-Approval-Study-of-the-C-Scan-R-System
3. Due to sample size, the study was not designed to be powered for statistical significance.
15Operations Ramp Up
• Enhancing infrastructure including investments in manufacturing equipment and personnel
• Building out global supply chain
• Hot line assembly of C-Scan for U.S. pivotal trial being conducted in collaboration with GE Healthcare
• Ongoing evaluation of post-pivotal trial manufacturing scalability
16Global Regulatory Pathway United States IDE Approval Breakthrough Device Designation Pivotal study initiation projected to begin by the end of the first quarter of 2022* Israel Israeli Ministry of Health (“AMAR”) approval obtained Ongoing additional clinical data collection EU CE Mark granted *Assuming the COVID-19 pandemic does not cause further interruptions in the Company's operations. Pending successful results of additional clinical data collection 17
Strong Global Intellectual Property Franchise
Core patents granted in major jurisdictions
C-Scan Core Patents Future potential applications
• X-ray capsule medical imaging • Drug delivery capsule
• 3D Real-time tracking • Microbiome sampling capsule
• 3D Recon algorithms • Catheter-based X-ray imaging
51 Granted 15
Pending
18Management Team
Alex Ovadia Yoav Kimchy, Ph.D. Mira Rosenzweig Vardit Segal, Ph.D.
Chief Executive Officer Founder & CTO Chief Financial Officer VP of Clinical Affairs
Joshua Belkar Boaz Shpigelman Israel Hershko Noa Reshef
VP of Operations VP of Research & Development VP QA&RA Director of Human Resources
19Board of Directors
Extensive Experience in Medical Technology Development and Commercialization
Steve Hanley Clara Ezed XQ Lin
Chairman
Dr. Mary Jo Yuval Yanai
Gorman
20Strategic Path Forward
2021 2022E 2023E
IDE Approval Initiation of Completion of U.S. Pivotal Study1,2
U.S. Pivotal Study (end of Q1)3
Breakthrough File with FDA1,2
Device Designation
FDA Approval1,2
Collection of additional clinical data in
preparation for pivotal study*
Operations ramp up, reimbursement strategy advancement and continued exploration of strategic partnerships
* Includes larger-scale study in Israel in subjects considered to be average risk
1. Pending sufficient capital
2. Assuming de novo classification, no PMA and no additional clinical studies required
3. Pending successful results of additional clinical data collection
Disclaimer: This timeline assumes that the COVID-19 pandemic does not cause further interruptions in the Company's operations 21Investment Summary
~935,173 CRC deaths and ~1.9M new cases of CRC globally annually
Significant Market Potential
Multibillion-dollar addressable market
Preparation-free test to detect polyps before they may transform into cancer
C-Scan® Value Proposition Opportunity for patients to take control of their health through preventive screening
Positive clinical data
Collaboration with GE Healthcare
Global Regulatory Pathway FDA IDE approval for U.S. pivotal study, planned to start by the end of Q1 2022*
CE marking in EU; AMAR approval in Israel
Strong Worldwide IP 46 patents granted; 2 allowed; 17 pending
Management experienced in navigating regulatory pathways
Experienced Leadership Team
and product launch/commercialization
HQ: Isfiya, Israel
NASDAQ: CHEK
General Information Number of employees: 67
Cash and equivalents: $34.0M as of March 31, 2021;
$35M capital raise completed on July 2, 2021
22
* Assuming the COVID-19 pandemic does not cause further interruptions in the Company's operationsAPPENDIX
Reimbursement for Screening Methods
Colonoscopy $1,2121
Out of pocket private sector average cost ($2,100 – $3,7642)
United States
Cologuard
$5093
(Stool DNA, Exact)
Capsule Endoscopy
Japan $785*4
(Medtronic)
*83,100 JPY in 2019 or $785USD (based on August 2019 rates).
Source:
1. Relates to estimated average cost with biopsies in 2015 https://link.springer.com/article/10.1007/s00261-015-0538-1
2. https://aspe.hhs.gov/system/files/pdf/255906/DHNAdditionalInfor.pdf, https://www.bankrate.com/finance/smart-spending/how-much-does-colonoscopy-cost.aspx
3. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ClinicalLabFeeSched/Downloads/CY2018-CLFS-Payment-System-Summary-Data.pdf 24
4. http://mayafiles.tase.co.il/rpdf/854001-855000/p854945-00.pdfX-Ray Exposure Control
Comparison of approximate effective radiation
dose in adults for several radiology procedures
9
8 7.7
7
6 6
Very Low Radiation Exposure 6
• Proximity of the capsule to the
mSv
5
scanning target allows for the use
4
of an ultra-low dose radiation
3
Low Environmental Impact 2
• Source half lifetime 15.4 days 1
0.05 0.1
• Almost undetectable radiation after
0
disposal C-Scan Chest X-ray CT–Colonography Barium Enema CT–Abdomen and
(Lower GI X-ray) Pelvis
Source: https://www.radiologyinfo.org/en/info.cfm?pg=safety-xray
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